Device for robot-assisted surgery

ABSTRACT

A device for robot-assisted surgery with at least one coupling unit (100) of a manipulator arm (16) comprising a first transmitting means (102). A sterile cover (38) comprising a sterile lock (200) serves to shield the manipulator arm (16) from a sterile area (39). The sterile lock (200) is connectable both to the coupling unit (100) and to the sterile unit (400). The sterile lock (200) has at least one lock flap (208, 210) which in a closed state shields the first transmitting means (102) in a sterile manner. The sterile unit (400) comprising a second transmitting means (406) has sterile flaps (402, 404) which in a closed state shield the second transmitting means (406) in a sterile manner. When connecting the sterile unit (400) to the sterile lock (200) the lock flap (208, 210) and the sterile flap (402, 404) are opened so that a direct transmission between the first transmitting means (102) and the second transmitting means (406) is possible. When separating the sterile unit (400) from the sterile lock (200) the lock flaps (208, 210) and the sterile flap (402, 404) are each automatically closed and locked so that they shield the first transmitting means (102) and the second transmitting means (406) from the sterile area (39). Further, the invention relates to a sterile lock (200) and a method for robot-assisted surgery.

This application is a National Phase application of InternationalApplication No. PCT/EP2015/076769, filed Nov. 17, 2015, which claims thebenefit of German Patent Application No. 102014117407, filed Nov. 27,2014, both of which are incorporated herein by reference in theirentireties.

The invention relates to a device for robot-assisted surgery, comprisingat least one manipulator arm arranged in a non-sterile area and having acoupling unit which has at least a first transmitting means. The devicehas at least one sterile unit arranged in a sterile area and having atleast a second transmitting means and a sterile cover for shielding themanipulator arm from the sterile area. The invention further relates toan arrangement for robot-assisted surgery which comprises such a devicefor robot-assisted surgery and at least one input device for the inputof at least one input command. Further, the invention relates to asterile lock, in particular for the use in such a device, as well as amethod for robot-assisted surgery in which a sterile unit is connectableto a manipulator arm several times in succession.

In minimally-invasive surgery, so-called telemanipulator systems, alsoreferred to as robot-assistance systems, are increasingly used. Thesterile surgical field is protected against the non-sterile elements ofthe telemanipulator system by means of a sterile cover. By means of thesterile cover both a contamination of the sterile surgical field and acontamination of the telemanipulator system by body fluids and/or tissueof the operated patient or of the surgical staff is prevented. Thisreduces the risk of cross-contamination.

By means of the telemanipulator system surgical instruments and/orendoscopes are controlled in their position and orientation on the basisof user inputs and, in doing so, inevitably come into physical contactwith the patient to be operated so that the surgical instruments and/orendoscopes are contaminated with body fluids and/or tissue of theoperated patient. At the same time, the surgical instruments have to becoupled mechanically, electrically and/or optically to thetelemanipulator system in order to be able to implement an activepositioning and orientation of the surgical instrument as well as adesired actuation of a surgical instrument. For this, the surgicalinstruments, endoscopes or medical devices to be operated have acoupling interface which may be designed as a coupling unit and is alsoreferred to as sterile unit.

The material used during a surgical operation including the employedsurgical apparatuses and instruments and the further components of thetelemanipulator system can be divided into three categories:

Category 1: The material is sterile and is contaminated during thesurgical operation. The material is disposed of after the operation.Thus, there is a one-time use of the material.

Category 2: The material is sterile, is contaminated during the surgicaloperation and is cleaned and sterilized after the operation. Thus, thereis a multiple use of the material. Such materials used multiple timesmust be designed and produced in accordance with the requirements on aprocess-capable sterilizability.

Category 3: The material is not sterile. During the surgical operation acontamination of the sterile surgical field is prevented by a sterilecover and over-packaging. At the same time, the non-sterile material isprotected against contact with body fluids and/or tissue.

If it is necessary to couple devices of category 1 or category 2 todevices of category 3, then a sterile interface is required whichprevents contamination of the devices of category 1 or category 2 by thenon-sterile devices of category 3 and, vice versa, prevents acontamination of the devices of category 3 since these are generallytechnically designed as autoclavable components that cannot besterilized. The realization of devices as autoclavable components thatcan be sterilized requires a particular technical design of the devicefor the sterilization process so that a higher development effort aswell as considerable validation effort for proving the effectiveness ofthe sterilization process are necessary for this. For such a proof, itis in particular necessary, multiple times in succession, to contaminateand sterilize the device and to perform an effectiveness check of thesterilization as well as a functionality check after sterilization.Here, proof has to be furnished that after each sterilization thedevices are reliably sterilized and thus could be used again.

From document U.S. Pat. No. 7,666,191 B1, a telemanipulator system isknown in which the non-sterile manipulator arms are covered by means ofa sterile drape. The coupling unit of the manipulator arm comprises fourrotation actuators which are coupled to a first side of a sterileadaptor integrated in the sterile drape. By means of the sterileadaptor, the rotary motions of the four rotation actuators of thecoupling unit of the manipulator arm are engaged with four rotatablymounted transmitting means integrated in the sterile adaptor. On thesterile outside surface of the sterile adaptor these steriletransmitting means on the outside surface of the sterile adaptor can beengaged with driven elements of the sterile surgical instrument.Further, via this sterile adaptor electrical signals can be transmittedbetween the inside and the outside of the sterile adaptor.

Thus, by means of the sterile adaptor it is prevented that the rotationactuators and the electrical connections of the sterile surgicalinstrument come into direct contact with the rotation actuators and theelectrical connections of the coupling unit of the non-sterilemanipulator arm. A contamination of the surgical instrument by thecontact with non-sterile parts of the manipulator arm is prevented bythe sterile adaptor. In this solution it is, however, essential that thesterile adaptor must have rotatably mounted transmitting means as wellas transmitting means for transmitting electrical signals, as a resultwhereof the adaptor is costly in production and is susceptible tointerference. In particular, it is costly to guarantee the rotatabilityof the transmitting means when the transmitting means come into contactwith body fluid.

Basically, each element in the chain of functions for coupling themanipulator arm and the instrument is a possible source of errors andinvolves additional costs. The sterile adapter itself is provided aspart of the sterile drape for a one-time use.

From document U.S. Pat. No. 8,074,657 B2, a further sterile adapter isknown which comprises an actuator unit for transmitting mechanicalenergy to a surgical instrument coupled to the sterile adapter.

It is the object of the present invention to specify a device and amethod for robot-assisted surgery, in which a sterile coupling of amanipulator arm arranged in a non-sterile area to a sterile unitarranged in a sterile area is easily possible. Further, an arrangementfor robot-assisted surgery within a sterile area as well as a sterilelock for coupling a coupling unit of an manipulator arm to a sterileunit are to be specified.

This object is solved by a device for robot-assisted surgery having thefeatures of claim 1 and by an arrangement, by a sterile lock and by amethod having the features of the respective independent claim.Advantageous developments of the invention are specified in thedependent claims.

In the invention, in particular by providing a sterile lock which isconnectable both to a coupling unit and to a sterile unit, the lock flapis opened, preferably automatically mechanically, when connecting thesterile unit to the sterile lock so that the first transmitting means ofthe coupling unit and the second transmitting means of the sterile unitare arranged opposite to each other without a further transmittingelement being arranged between them. The transmitting means can directlycontact each other, or there is a transmission via an air gap betweenthe first transmitting means and the second transmitting means. As aresult, when connecting the sterile unit to the sterile lock, the firsttransmitting means covered by the lock flap in a sterile manner isuncovered for a transmission with the second transmitting means. Whenseparating the sterile unit from the sterile lock, at least the firsttransmitting means is again shielded in a sterile manner. Preferably,the sterile lock is already connected to the coupling unit whenconnecting and separating the sterile unit to or from the sterile lock,respectively. Preferably, the sterile lock remains connected to thecoupling unit throughout the entire period of time of the surgicaloperation, wherein the sterile unit can be separated from andre-connected to the coupling unit of the manipulator arm multiple timesor can be replaced by a further sterile unit. Further, it is possible toconnect the sterile lock to the coupling unit and the sterile unit suchthat the first transmitting means is directly connected to the secondtransmitting means, preferably directly engaged therewith.

By means of the invention it is in particular possible to provide thesterile lock without mechanical and/or electrical transmitting means sothat both a reliable sterile shielding of the non-sterile manipulatorarm and the non-sterile coupling unit as well as a reliable coupling ofthe first transmitting means to the second transmitting means withoutany interconnection of further transmitting means, in particular withoutinterconnecting further mechanical transmitting means is possible. Thesterile cover in particular comprises a sterile flexible material, suchas a sterile foil, and the at least one sterile lock.

It is advantageous when the sterile unit has at least one sterile flapwhich in a closed state shields the second transmitting means in asterile manner. When connecting the sterile unit to the sterile lockthen each time a movement of the lock flap and the sterile flap from theclosed state into the open state takes place so that a directtransmission between the first transmitting means and the secondtransmitting means through an opening uncovered by the lock flap and thesterile flap in the open state is possible. When separating the sterileunit from the sterile lock, a movement of the lock flap and the sterileflap each time from the open state into the closed state takes place sothat after separation the lock flap shields the first transmitting meansfrom the sterile area and the sterile flap shields the secondtransmitting means from the sterile area.

Preferably, the first transmitting means of the coupling unit comprisesat least one drive element and/or at least a first electrical interfaceand/or at least a first optical interface. The second transmitting meansof the sterile unit comprises at least a driven element and/or a secondelectrical interface and/or at least a second optical interface. Thesterile lock is connectable to the coupling unit and the sterile unitsuch that the at least one drive element is mechanically directlyengaged with the at least one driven element. As a result, torques caneasily and safely be transmitted between the coupling unit and thesterile unit. If the sterile unit forms part of a surgical instrumentunit, by means of the torques transmitted from the coupling unit to thesterile unit the surgical instrument of the instrument unit can be movedand/or actuated in that at least a torque is transmitted from the driveelement to the driven element. Alternatively or additionally, the firstelectrical interface can be coupled to the second electrical interfaceand/or the first optical interface can be coupled to the second opticalinterface.

According to the definition in the introductory part of the description,the sterile unit is material of category 1 and 2 and is thus sterile.

Further, it is advantageous when the coupling unit is connectable to afirst connecting area of the sterile lock and when the sterile unit isconnectable to a second connecting area of the sterile lock. The firstconnecting area and the second connecting area are preferably arrangedon sides of the sterile lock facing away from each other. As a result,an easy coupling and thus an easy handling both of the sterile cover andof the sterile unit before, during and after the surgical operation ispossible. Further, it is particularly advantageous when the secondconnecting area is designed as a receiving area in which the sterileunit is receivable at least in part when it is connected to the secondconnecting area. As a result, an easy and reliable connection betweenthe sterile unit and the sterile lock can be established. In particular,the sterile unit can at least in part be pressed into the receiving areaand be locked therein.

Further, it is advantageous when the sterile lock has a third connectingarea with which the flexible cover is connectable, wherein the thirdconnecting area is arranged preferably circumferentially around thesterile lock, in particular on the circumferential surface, preferablybetween the first and second connecting area. By means of the sterilelock an easy connection of the sterile area and the non-sterile area forcoupling the coupling unit to the sterile unit is established, withoutthe sterile unit being contaminated such that it can no longer remain inthe sterile area after a separation from the sterile lock.

Preferably, the coupling unit is arranged at the proximal end of themanipulator arm. Alternatively or additionally, the sterile unit formspart of a surgical instrument, an endoscope and/or a medical device,wherein the sterile unit is arranged in particular at the distal end ofthe surgical instrument, the endoscope and/or the medical device. As aresult, the sterile lock can be used for various instruments and devicesrequired during a surgery on a patient without different sterile locksor sterile locks with different modes of action have to be used.

Further, it is advantageous when the first connecting area of thesterile lock is connectable to the coupling unit via a first releasablesnap-in connection and the second connecting area of the sterile lock isconnectable to the sterile unit via a second releasable snap-inconnection. As a result, the sterile lock is reliably connectable toboth the coupling unit and the sterile unit and is easily separable fromthese again so that an easy handling both of the sterile cover with thesterile lock and of the sterile unit, in particular during a surgicaloperation, is possible.

It is particularly advantageous when the coupling unit comprises atleast one coupling sensor which detects the presence of a sterile unitthat is correctly connected to the sterile lock. Further, the device hasa control unit which only allows a transmission between the firsttransmitting means and the second transmitting means when a sterile unitthat is correctly connected to the sterile lock has been detected bymeans of the coupling sensor. In a further advantageous embodiment thecoupling sensor detects by means of a detection element which isprovided on the sterile unit and which, when connected to the sterilelock, projects up into the first connecting area with which the couplingunit is connected, that both the sterile unit is correctly connected tothe second connecting area and the coupling unit is correctly connectedto the first connecting area. The control unit preferably only enablesor only permits a transmission between the first transmitting means andthe second transmitting means when the coupling sensor has detected acorrect connection between the sterile unit and the second connectingarea and the coupling unit and the first connecting area.

In addition, by means of the coupling sensor it can easily be detectedwhether at least the sterile unit is correctly connected to the sterilelock so that then it can be assumed that the sterile unit is correctlyconnected to the sterile lock and, via the sterile lock, is correctlyconnected to the coupling unit of the manipulator arm. As a result, asafe transmission between the first transmitting means and the secondtransmitting means is possible.

Further, it is advantageous when the coupling unit has several driveelements as a first transmitting means and when the sterile unit hasseveral driven elements as a second transmitting means. The driveelements are then directly mechanically engaged with the driven elementsfor a mechanical coupling of the coupling unit with the sterile unitwhen connecting the sterile unit with the sterile lock given aconnection of the coupling unit to the sterile lock. Alternatively oradditionally, the coupling unit has at least two first electricalcontact elements as a first transmitting means and the sterile unit hastwo second electrical contact elements which are complementary to thefirst electrical contact elements as a second transmitting means. Thefirst contact elements and the second contact elements establish adirect electrical connection between the coupling unit and the sterileunit when the coupling unit is connected to the sterile lock and whenthe sterile unit is connected to the sterile lock. This electricalconnection can in particular be used for transmitting high-frequencyelectrical energy, in particular for high-frequency surgery. Thus, thesterile unit can form part of a surgical high-frequency instrument. Ifseveral drive elements and several driven elements are provided,different movements and/or actuations of a surgical instrument coupledto the coupling unit via the sterile unit are easily possible.

It is particularly advantageous when the lock flap separates the firstconnecting area from the second connecting area and when the lock flapautomatically opens when the sterile unit is connected to the secondconnecting area. When separating the sterile unit from the secondconnecting area, the lock flap automatically closes. As a result, aneasy and safe covering of the non-sterile elements of the coupling unitis possible so that contaminations of the sterile area by non-sterileelements of the coupling unit are easily prevented. Here, it isadvantageous when the lock flap is automatically unlocked whenconnecting the sterile unit to the second connecting area and when thelock flap is automatically locked when separating the sterile unit fromthe second connecting area. As a result, a safe covering of thenon-sterile elements of the coupling unit is guaranteed. An inadvertentopening of the lock flap, such as by contact, is effectively preventedeasily.

Further, it is advantageous when the sterile flap of the sterile unitcovers the at least one second transmitting means and when the sterileflap opens automatically when connecting the sterile unit to the secondconnecting area, and when the sterile flap automatically closes whenseparating the sterile unit from the second connecting area. As aresult, also the possibly contaminated second transmitting means issafely shielded in a sterile manner when the sterile unit has again beenseparated from the sterile lock.

Further, it is advantageous when the sterile flap is automaticallyunlocked when connecting the sterile unit to the second connecting areaand when the sterile flap is automatically locked when separating thesterile unit from the second connecting area. By way of the automaticlocking and unlocking an inadvertent contact with the secondtransmitting means of the sterile unit contaminated by a possiblecontact between the first transmitting means and the second transmittingmeans is easily prevented in that the second transmitting means areshielded by means of the sterile flap and the latter is safely locked sothat an inadvertent contact with the second transmitting means after theseparation of the sterile unit from the sterile lock is not possible.

Further, it is advantageous when the sterile outside of the sterile flapis arranged opposite to the sterile outside of the lock flap facing thesecond connecting area when connecting the sterile unit to the secondconnecting area, when both the sterile flap and the lock flap are open.It is particularly advantageous when the sterile outsides of the sterileflap and the lock flap face each other in the open state, preferablycontact each other. By the facing arrangement of the sterile outside ofthe lock flap and the sterile outside of the sterile flap acontamination of the outside of the respective other flap is notpossible since only the insides can be contaminated by a contact with atleast one non-sterile transmitting element.

It is particularly advantageous when the sterile unit forms part of asurgical instrument, the sterile unit in particular being arranged atthe distal end of the surgical instrument.

It is particularly advantageous when the sterile cover and/or thesterile lock are made of polyethylene, polyurethane and/orpolycarbonate. As a result, both an easy manufacturing of the cover orthe sterile lock and an easy and safe handling of the cover and thesterile lock are possible.

The surgical instrument preferably comprises at least one end effectorinsertable into an orifice of the body of a patient, such as a clamp, apair of scissors, a grasper, a needle holder, a micro dissector, aclamping device, a staple applier, a rinsing and/or an aspirationdevice, a cutting blade, a cauterization probe, a catheter and/or asuction nozzle. As a result, the surgical instrument can optionally havedifferent end effectors which can be used for common minimally-invasivesurgeries, in particular in laparoscopic surgery. However, also othersurgical instruments can be used additionally or alternatively. Inparticular, the surgical instrument can also be an optical surgicalinstrument, such as an endoscope, which then has further optical andelectrical transmitting means or interfaces, such as electrical contactsfor camera control or for image data transmission, optical fiberconnections, in particular for illumination.

A second aspect of the invention relates to an arrangement forrobot-assisted surgery, in particular to a telerobot-assisted procedurewithin a sterile field by means of a sterile surgical instrument. Thisarrangement comprises at least one device according to claim 1 oraccording to an afore-mentioned development; a display unit whichoutputs in real time at least one image of the field of operation inwhich the end effector of the surgical instrument can be, preferably asan image sequence, and at least one device for the input of at least oneinput command. The arrangement further has a control unit whichpositions the manipulator arm and the sterile unit connected via thesterile lock to the coupling unit of the manipulator arm dependent onthe input command by means of at least one drive unit. As a result, aneasy control of the manipulator arm for positioning the sterile unitand/or an actuation for actuating the sterile unit is easily possible.Preferably, the input device has an actuating element actuatable by auser, such as a surgeon, wherein the input device detects a change ofposition in space of the actuating element and generates an inputcommand corresponding to the detected change of position in space.Dependent on the input command the control unit generates at least onecontrol command by which the same or a scaled down change of position inspace of at least an end of the sterile unit and/or of the surgicalinstrument, at the distal end of which the sterile unit is arranged, iscaused and/or by which an actuation or a reduced actuation of thesurgical instrument, at the distal end of which the sterile unit isarranged, is caused. As a result, an easy positioning and/or actuationof the surgical instrument by an operator who is remote from the patientin the operating room or outside the operating room is easily possible.As an output of an image in real time the immediate output of an imagedetected by means of an image detection unit preferably as a videosequence without delays going beyond the delays occurring during imageprocessing.

Further, it is advantageous when the arrangement has several devices forrobot-assisted surgery according to claim 1 or according to a mentioneddevelopment. The input device has preferably at least two actuatingelements actuatable by a user, wherein the input device detects a changeof position in space of each actuating element and generates each timean input command corresponding to the detected change of position inspace. Dependent on each input command, the control unit generates atleast one control command each by which the same or a scaled up/downchange of position in space of at least one end of a surgicalinstrument, at the distal end of which the sterile unit is arranged, ofthe device for robot-assisted surgery assigned to the respectiveactuating element at the point in time of the actuation is caused and/orby which an actuation or a scaled actuation of this surgical instrumentis caused. As a result, the operation can be performed with severalinstruments which are present in the operating field at the same time orwhich, in the case of laparoscopic surgeries, are present in theabdominal cavity of the patient at the same time.

A third aspect of the invention relates to a sterile lock which is inparticular suitable for use in a device for robot-assisted surgeryaccording to claim 1 or a development of this device. The sterile lockhas a first connecting area for connecting the sterile unit to anon-sterile coupling unit and a second connecting area for connectingthe sterile lock to a sterile unit arranged in a sterile area. Thesterile lock further has a circumferential third connecting area forconnecting the sterile lock to a flexible sterile cover for separatingthe sterile area from the non-sterile area. Further, the sterile lockhas at least one lock flap which in a closed state closes an openingbetween the first connecting area and the second connecting area in asterile manner and in an open state uncovers the opening between thefirst connecting area and the second connecting area. By way of such asterile lock, an easy handling of the sterile unit when connecting thelatter to the coupling unit is made possible, wherein both thenon-sterile transmitting means of the coupling unit are shielded in asterile manner and a direct coupling of a first transmitting meansarranged in the coupling unit to a second transmitting means arranged inthe sterile unit is easily possible. In particular, drive elements ofthe coupling unit and driven elements of the sterile unit can bedirectly engaged when the lock flap is open.

It is particularly advantageous when the sterile lock is connectable tothe sterile unit and to the coupling unit such that at least a driveelement of the coupling unit serving as a first transmitting element ismechanically directly engaged with at least one drive element of thesterile unit serving as a second transmitting means. By the directmechanical engagement, torques can be transmitted from the drive elementto the driven element so that a transmission of torques between thenon-sterile area and the sterile area through the sterile lock is easilypossible without interconnecting further transmitting means. Thus,additional transmitting means for connecting the drive elements and thedriven elements are not necessary. Such transmitting means are bothsusceptible to failure and can only be integrated in a sterile cover ina relatively complex manner.

It is particularly advantageous when the third connecting area of thesterile lock is arranged at an outside of the sterile lock between thefirst connecting area and the second connecting area. In particular, thethird connecting area is arranged circumferentially on a circumferentialsurface of the sterile lock. The connection between the sterile lock anda sterile flexible covering material can be established via a clamping,Velcro, welding and/or adhesive connection. As a result, the sterileflexible cover material can easily be connected to the outside of thesterile lock so that the cover material together with the sterile lockforms a continuous sterile cover.

For forming a clamping connection, the third connecting area can bedesigned as a clamping area so that the flexible cover material can beconnected to the clamping elements of the third connecting area.Alternatively or additionally, the third connecting area can be formedas an adhesive area by which the sterile flexible covering material isconnectable to the third connecting area by means of adhesive.Alternatively or additionally, the sterile flexible covering materialcan be connected to the third connecting area via a welding connection.

Further, it is advantageous when the lock flap automatically opens whenconnecting the sterile unit to the first connecting area and when thesterile lock automatically closes again when separating the sterile unitfrom the first connecting area. The opening and closing of the lock flappreferably takes place mechanically, wherein the lock flap is openedagainst spring force and can be closed by spring force. Preferably, thelock flap is locked in the closed state so that it cannot be opened by aforce on the closed lock flap. As a result, an easy and safe handling ofthe sterile lock is possible. In particular, non-sterile areas of thecoupling unit are covered by means of the lock flap when the sterileunit is not connected to the sterile lock.

A fourth aspect of the invention relates to a method for robot-assistedsurgery, in particular by using a device according to claim 1 or anabove-described development, an arrangement according to the secondaspect of the invention or a development of this arrangement or by usinga sterile lock according to the third aspect of the invention or aspecified development of this sterile lock. In the method, a manipulatorarm arranged in the non-sterile area is shielded from the sterile areaby means of a sterile cover and a sterile lock integrated in the cover.A non-sterile coupling unit of the manipulator arm is connected to afirst connecting area of the sterile lock. An opening between the firstconnecting area and a second connecting area of the sterile lock isclosed by means of a sterile flap. The lock flap is automatically openedwhen connecting a sterile unit arranged in a sterile area to the secondconnecting area of the sterile lock so that a direct transmissionbetween the first transmitting means and the second transmitting meansof the sterile unit is possible in case of an open lock flap. By openingthe lock flap, the opening between the first connecting area and thesecond connecting area is open.

The lock flap is automatically closed when separating the sterile unitfrom the second connecting area, as a result whereof the opening betweenthe first connecting area and the second connecting area is again closedin a sterile manner. The lock flap is again automatically opened whenconnecting the sterile unit arranged in the sterile area or a furthersterile unit arranged in the sterile area to the second connecting areaof the sterile lock so that a direct transmission between the firsttransmitting means and the second transmitting means or a further secondtransmitting means of the further sterile unit is again possible. As aresult, an easy coupling between the coupling unit and the sterile unitis possible, wherein the sterile unit, if necessary, can be separatedfrom the sterile lock several times without contaminating the sterilearea. This is guaranteed even when the second transmitting means hasbeen contaminated, in particular by a contact with the firsttransmitting means.

In particular when the sterile unit is used only once, it does not haveto have a sterile flap. The sterile unit is then immediately removedfrom the sterile area after separation from the sterile lock during asurgery.

However, it is advantageous when the sterile unit has at least onesterile flap which in a closed state shields the second transmittingmeans in a sterile manner. The lock flap and the sterile flap are eachmoved from the closed state into the open state when connecting thesterile unit to the sterile lock so that a direct transmission betweenthe first transmitting means and the second transmitting means throughan opening uncovered by the sterile flap and the lock flap in the openstate is possible. When separating the sterile unit from the sterilelock, the lock flap and the sterile flap are each moved from the openstate into the closed state so that after separation the firsttransmitting means is shielded from the sterile area by means of thelock flap and the second transmitting means is shielded from the sterilearea by means of the sterile flap.

Here, it is advantageous when the opening of the sterile unit is closedby the sterile flap in its closed state such that the secondtransmitting means is arranged behind the sterile flap and when thesterile flap upon connection to the sterile lock is opened such that anaccess to the second transmitting means is possible. Preferably, thesterile flap is automatically opened when connecting the sterile unit tothe second connecting area of the sterile lock. When separating thesterile unit from the second connecting area of the sterile lock, thesterile flap is automatically closed. As a result, a safe handling ofthe sterile unit and of the sterile lock together with a non-sterilecoupling unit is possible.

Further, it is advantageous when the first transmitting means comprisesat least one drive element and when the second transmitting meanscomprises at least one driven element. During connection of the sterileunit to the second connecting area of the sterile lock, the lock flap ofthe sterile lock and a sterile flap of the sterile unit are opened suchthat during connection of the sterile unit to the second connecting areathe drive element is directly engaged with the driven element. Inparticular, this takes place without interconnecting furthertransmitting means, in particular without interconnecting a movedtransmitting means so that a contamination of at least the outside ofthe sterile unit is safely prevented, as a result whereof the sterileunit, even after separation from the sterile lock, can simply remain inthe sterile area and can be placed thereat.

Here, it is not a disadvantage when the sterile driven element iscontaminated upon first contact with the drive element because thecontaminated driven element is shielded by the sterile flap in a sterilemanner while separating the sterile unit from the second connectingarea. Preferably, when separating the sterile unit from the firstconnecting area both the lock flap and the sterile flap are closed andpreferably locked such that each time an access area to the driveelement and to the driven element are shielded in a sterile manner.Preferably, the sterile flap and the lock flap are mechanically lockedin the closed state so that neither the lock flap nor the sterile flapcan be opened manually. As a result, a sterile covering of non-sterileor contaminated elements of the coupling unit and of the sterile unit isguaranteed so that the sterile area is not contaminated even afterseparating the sterile unit from the sterile lock.

Altogether, an inventive method enables an easy and safe handling, inparticular an easy and safe exchange of the sterile unit, in particularof an instrument unit comprising the sterile unit with a surgicalinstrument during a surgical intervention.

In all embodiments and developments, the sterile lock can have two lockflaps and the sterile unit can have two sterile flaps.

In all described embodiments, the sterile lock forms no part of thechain of functions for the transmission of electrical energy, ofelectrical or optical signals and/or mechanical energy between themanipulator arm and the sterile unit. Rather, the sterile lock cancomprise a fixed form part and a lock flap system comprising at leastthe lock flap, which shields the non-sterile first transmitting means ofthe coupling unit such that this one and the entire coupling unit arecovered in a sterile manner relative to the sterile surrounding aftermounting the sterile cover with the sterile lock. The opening mechanismof the lock flap system is preferably designed such construction-wisethat it cannot be opened from outside by inadvertent actuation. Further,also the second transmitting means are shielded by a sterile housing ofthe sterile unit and by the at least one sterile flap of the sterileunit in a sterile manner. These second transmitting means in particularcomprise at least one driven element, preferably at least one drivenelement for taking up rotatory operating forces and a driven element fortaking up translatory operating forces are provided.

In addition, at least one electrical connection for transmittinghigh-frequency energy for high-frequency surgery can be provided. It isparticularly advantageous when the sterile unit has at least two drivenelements for taking up rotatory operating forces and two driven elementsfor taking up translatory operating forces. The coupling unit of themanipulator arm then has two drive units as first transmitting means forgenerating rotatory operating forces, each of which being directlyengaged with the complementary driven elements serving as secondtransmitting means for taking up the rotatory operating forces of thesterile unit. Further, the coupling unit has as a first transmittingmeans two drive elements for generating translatory operating forceswhich drive elements are directly engaged with driven elements servingas a second transmitting means for taking up translatory operatingforces. A surgical instrument comprising the sterile unit is inparticular a laparoscopic instrument.

Preferably, opening mechanisms of the sterile flap system and/or of thelock flap system are designed such construction-wise that they cannot betriggered from outside by inadvertent actuations but only in the case ofa correct coupling of the sterile unit to the sterile lock. The openingmechanism of the sterile flap system and of the lock flap system arepreferably designed such construction-wise that when connecting thesterile unit to the sterile lock the flaps of the lock flap system andof the sterile flap system are automatically unlocked and opened bycorresponding engaging elements. In this way, the drive elements servingas transmitting means and the driven elements as well as electricalcontact elements can be directly engaged or brought into contact withone another. Thus, a direct connection between the non-sterile driveelements of the coupling unit and the driven elements of the sterileunit of a surgical instrument can be established. As a result, thepreviously sterile driven elements of the sterile unit may becontaminated.

When the sterile unit is again separated from the sterile lock, both thelock flaps of the lock flap system of the sterile lock and the sterileflap of the sterile flap system of the sterile unit are again closed, inparticular before the sterile unit has been completely removed from thesterile lock. Thus, it is guaranteed that at no point in time both thenon-sterile parts of the coupling unit and the no longer sterile drivenelements of the sterile unit and/or the electrical contacts of thesterile unit can come into contact with the sterile surgical field andthe patient environment and could contaminate the same. As a result, thesterile unit with the closed sterile flap system can be directly placedin the sterile patient environment and thus be kept ready until are-use, i.e. up to a re-connection to the first connecting area of thesterile lock without a contamination of the sterile patient environment.

The drive elements serving as first transmitting means and the drivenelements serving as second transmitting means are preferably designedsuch that a laparoscopic surgical instrument can be moved in altogetherfour degrees of freedom, namely:

-   1. Rotation of the instrument shaft-   2. Rotation of the instrument tip independent of the instrument    shaft-   3. Bending of the instrument tip relative to the instrument shaft-   4. Actuation of the surgical instrument, in particular for    generating a relative movement of two elements arranged movably to    each other, such as the grasping motion of the instrument tip or of    blades of scissors.

During the connection to the sterile lock, the sterile housing of thesterile unit is preferably pressed into a receiving area of the secondconnecting area and secured by means of a mechanical detent on thesterile lock against inadvertent removal. The mechanical detent thuscreates a snap-in connection between the sterile lock and the sterileunit. For separating the sterile unit from the sterile lock an unlockingbutton is actuated manually so that the sterile unit is separated fromthe second connecting area, preferably can be removed from the receivingarea of the second connecting area.

In general, an end of an arbitrary element facing the patient isconsidered as proximal. In general, an end of an element facing awayfrom the patient is considered as distal.

Further features and advantages result from the following descriptionwhich explains the invention in more detail on the basis of embodimentsin connection with the enclosed Figures.

FIG. 1 shows a schematic illustration of a system for robot-assistedsurgery comprising a manipulator having four manipulator arms to each ofwhich one sterile unit of an instrument unit is connectable.

FIG. 2 shows a front view of the manipulator illustrated in FIG. 1.

FIG. 3 shows a perspective illustration of a part of a manipulator armwith a coupling unit for coupling the manipulator arm to an instrumentunit comprising a sterile unit, a sterile lock coupled to the couplingunit, and a sterile unit of the instrument unit coupled to the sterilelock.

FIG. 4 shows a further perspective illustration of the arrangementaccording to FIG. 3.

FIG. 5 shows an arrangement for connecting the instrument unit arrangedin a sterile area to the non-sterile coupling unit of a manipulator arm.

FIG. 6 shows a schematic illustration of the coupling unit of themanipulator arm.

FIG. 7 shows a longitudinal section of the coupling unit according toFIG. 6.

FIG. 8 shows a perspective illustration of the sterile lock with closedand locked sterile flaps.

FIG. 9 shows a perspective illustration of the sterile lock according toFIG. 8 with open sterile flaps.

FIG. 10 shows a partial sectional side view of the sterile lock.

FIG. 11 shows a sectional illustration of the sterile lock according toFIG. 10 along the sectional line A-A.

FIG. 12 shows a sectional illustration of the sterile lock according toFIG. 10 along the sectional line B-B.

FIG. 13 shows a sectional illustration of the sterile lock according toFIG. 10 along the sectional line C-C.

FIG. 14 shows a detailed view with partially open sterile flaps and witha guiding fork engaged with the sterile flaps.

FIG. 15 shows a perspective illustration of the instrument unit withopen sterile flaps of the sterile unit.

FIG. 16 shows a perspective illustration of the instrument unitaccording to FIG. 15 with closed sterile flaps.

FIG. 17 shows a side view of the instrument unit.

FIG. 18 shows a sectional illustration of the instrument unit accordingto FIG. 17 along the sectional line E-E.

FIG. 19 shows a sectional illustration of the instrument unit accordingto FIG. 17 along the sectional line F-F.

FIG. 20 shows a detail of a bottom view of the instrument unit withclosed and locked sterile flaps.

FIG. 21 shows the detail of the instrument unit according to FIG. 20with unlocked and open sterile flaps.

FIG. 22 shows a top view of the sterile flap system of the sterile unitwith closed sterile flaps.

FIG. 23 shows a sectional illustration of the sterile flap systemaccording to FIG. 22 along the sectional line G-G.

FIG. 24 shows a top view of the sterile flap system according to FIGS.22 and 23 with open sterile flaps.

FIG. 25 shows a sectional illustration of the sterile flap systemaccording to FIG. 24 along the sectional line H-H.

FIG. 26 shows a perspective detailed view of the sterile flap with aguiding flap of the sterile unit.

FIG. 27 shows a top view of the guiding flap and the sterile flapaccording to FIG. 26 in a locked state.

FIG. 28 shows a top view of the sterile flap and the guiding flap in anunlocked state.

FIG. 29 shows a perspective illustration of the sterile flap and of theguiding flap in the open state.

FIG. 30 shows a partial sectional illustration of an arrangement withthe sterile unit and the sterile lock in a connected state.

FIG. 31 shows a sectional illustration of the arrangement according toFIG. 30 along the sectional line I-I.

FIG. 32 shows a sectional illustration of the arrangement according toFIG. 30 along the sectional line J-J.

FIG. 33 shows a sectional illustration of the arrangement according toFIG. 30 along the sectional line K-K.

FIG. 34 shows a sectional illustration of the arrangement according toFIG. 30 along the sectional line L-L.

FIG. 35 shows elements of a sterile flap system of the sterile unit andof a lock flap system of the sterile lock of the arrangement accordingto FIGS. 30 to 34.

FIG. 36 shows a side view of the arrangement according to FIGS. 30 to35.

FIG. 37 shows a sectional illustration of the part of the arrangementaccording to FIG. 36 along the sectional line M-M.

FIG. 38 shows a sectional illustration of the arrangement according toFIG. 36 along the sectional line N-N.

FIG. 39 shows a top view of an arrangement of the coupling unit, sterilelock and instrument unit.

FIG. 40 shows a sectional illustration of the arrangement according toFIG. 39 along the sectional line O-O in a first position for connectingthe instrument unit to the sterile lock coupled to the coupling unit.

FIG. 41 shows a sectional illustration of the arrangement according toFIG. 39 along the sectional line O-O in a second position for connectingthe instrument unit to the sterile lock coupled to the coupling unit.

FIG. 42 shows a sectional illustration of the arrangement according toFIG. 39 along the sectional line O-O in a third position for connectingthe instrument unit to the sterile lock coupled to the coupling unit.

FIG. 43 shows a detail of an instrument unit according to a secondembodiment.

FIG. 44 shows a sterile cover with a sterile lock according to a secondembodiment.

FIG. 45 shows a detail of an instrument unit according to a thirdembodiment.

FIG. 46 shows a sterile cover with a sterile lock according to a thirdembodiment.

FIG. 1 shows a schematic illustration of a system 10 for robot-assistedsurgery with a manipulator 12 having a mount 14 and four manipulatorarms 16 a to 16 d. In other embodiments, the manipulator 12 can alsohave more or less manipulator arms 16 a to 16 d. Each manipulator arm 16a to 16 d is connected to a sterile instrument unit 300 a to 300 d via acoupling unit of the manipulator arm 16 a to 16 d. The instrument unit300 a to 300 d is sterile and comprises in addition to the sterile unitfor coupling the instrument unit 300 a to 300 d to the coupling unit ofthe manipulator arm 16 a to 16 d, a surgical instrument, in particularan end effector, wherein the end effector can be moved and/or actuatedby means of the coupling unit of the manipulator arm 16 a to 16 d.Alternatively to the surgical instrument, the instrument unit 300 a to300 d can also comprise an optical instrument, in particular anendoscope, and/or a medical device, in particular for the application ofa medicine, for dispensing a rinsing fluid and/or for aspiration ofrinsing fluid and/or secretion.

The mount 14 has a mount base 24 standing on the floor of an operatingroom. The manipulator arms 16 a to 16 d are connected to a mount head 20of the mount 14. In other embodiments, the mount can also be a ceilingmount.

The position of the mount head 20 is adjustable by means of a firstdrive unit 22 and by means of a second drive unit 26 arranged in themount base 24. By means of the drive unit 22, mount arms 28, 30 aremovable relative to each other. By means of the drive unit 26, theinclination of the mount arm 30 relative to the support surface of themount base 24 can be changed and/or the mount arm 30 can be rotatedabout a vertical axis of rotation. In general, the positioning of themount head 20 takes place prior to a surgery of a patient. During thesurgery, the position of the mount head 20 relative to the column 32 ofan operating table 34 normally remains unchanged. The manipulator 12 iscontrolled by means of a control unit 36. The control unit 36 isconnected via a data and/or control line to an input and output unit 37which in particular outputs an image of the operation field to a user inreal time by means of at least one display unit. The user makes userinputs by which the instrument units 300 a to 300 d are positioned andactuated during the operation of the patient. The input and output unit37 thus serves as a human machine interface.

The control unit 36 is further connected via a control and/or dataconnection to a non-illustrated control unit of the operating table 34.Via this control and/or data connection it is guaranteed that theposition of the patient support surface or of segments of the patientsupport surface of the operating table 34 can only be changed when thisis safely possible for a patient to be operated owing to the positioningof the instruments units 300 a to 300 d.

The operating table 34 as well as the instrument units 300 a to 300 dare arranged in a sterile operating area 39. The manipulator arms 16 ato 16 d and the mount 14 are not sterile. The areas of the manipulator12 projecting into the sterile operating area 39, i.e. the manipulatorarms 16 a to 16 d, the mount head 20 and a part of the mount arm 28 arepacked in a sterile manner in a sterile flexible cover 38, such as asterile foil, indicated by means of the broken line, so that they can besafely arranged in the sterile operating area 39. The input and outputunit 37 is arranged outside the sterile area 39 and thus does not haveto be packed in a sterile manner.

In a large number of surgeries the instrument units 300 a to 300 d haveto be changed several times during the surgery owing to the course ofthe surgery. Thus, between the manipulator arm 16 a to 16 d and theinstrument unit 300 a to 300 d a sterile interface has to be providedwhich guarantees that the non-sterile parts of the coupling unit of themanipulator arm 16 a to 16 d are covered in a sterile manner even afterthe separation of the instrument unit 300 a to 300 d. In addition,elements of the instrument unit 300 a to 300 d contaminated by a contactof the sterile elements of the coupling unit of the manipulator arm 16 ato 16 d have to be covered in a sterile manner after the separation ofthe instrument unit 300 a to 300 d from the manipulator arm 16 a to 16 dso that the instrument unit 300 a to 300 d can be placed in the sterilearea 39 without contaminating further elements in the sterile area 39.According to the invention, a sterile lock is provided between thecoupling unit of the manipulator arm 16 a to 16 d and the instrumentunit 300 a to 300 d, which comprises at least one lock flap that isclosed when no instrument unit 300 a to 300 d is connected to thesterile lock so that then the non-sterile coupling unit is shielded fromthe sterile area 39 by means of the flexible sterile cover 38 and thesterile lock integrated therein. The structure and the function of thesterile lock are still described in more detail in the following inconnection with FIGS. 3 to 42.

In FIG. 2, a front view of the manipulator 12 according to FIG. 1 isshown. The manipulator arms 16 a to 16 d of the manipulator 12 each haveseveral segments 40 a to 58 a which are movable relative to each otherby means of integrated drive units so that the instrument units 300 a to300 d can be positioned accurately without collision. The sterile covers38 for shielding a part of the manipulator arms 16 a to 16 d are notillustrated in FIG. 2. The segments of the manipulator arm 16 a areidentified with the reference signs 40 a to 58 a. The furthermanipulator arms 16 b to 16 d have the same structure and have thesegments 40 b to 58 b, 40 c to 58 c and 40 d to 58 d not identified inFIG. 2 for reasons of clarity. The same elements of the manipulator arms16 a to 16 d are identified with the same reference sign and theadditional letter for distinguishing the manipulator arms 16 a to 16 d.The statements made in the following description refer to themanipulator arm 16 a and the instrument unit 300 a which are identifiedin the following with manipulator arm 16 and instrument unit 300. Thesegments 40 a to 58 a of the manipulator arm 16 a are identified in thefollowing as segments 40 to 58. The explanations, however, apply in thesame manner to the identically constructed manipulator arms 16 b to 16 dand the instrument units 300 b to 300 d. Elements having the samestructure and/or the same function are identified with the samereference signs.

FIG. 3 shows a perspective illustration of a part of the manipulator arm16 with a coupling unit 100 for coupling the manipulator arm 16 to theinstrument unit 300 comprising a sterile unit 400. For this, thecoupling unit 100 is connected to a sterile lock 200 integrated in thesterile cover 38. The sterile lock 200 is couplable and again separableboth to the coupling unit 100 and to the sterile unit 400. In FIG. 3,the sterile lock 200 is illustrated so as to be coupled both to thecoupling unit 100 and to the sterile unit 400. The coupling unit 100 isarranged at the distal end of the telescopic arrangement 60.

The telescopic arrangement 60 has sections 62, 64, 66 movable to eachother and is illustrated in FIG. 3 in an extended state. The sections62, 64, 66 of the telescopic arrangement 60 can be retracted andextended by means of a drive unit 68 so that a surgical instrument 500of the instrument unit 300 can be moved along the longitudinal axis 510of the instrument shaft 512 together with the coupling unit 100, thesterile lock 200 and the sterile unit 400. By means of a drive unitintegrated into the segment 52, the segment 54 can be rotated about theaxis of rotation 57 together with the segment 56 designed as anarticulated arm. The segment 58 is connected to the segment 56 via acoupling gear mechanism 59 so that the segment 58 can be pivoted aboutthe axis of rotation 61 after activation of a drive unit connected tothe coupling gear mechanism 59. Further, the coupling unit 100 isarranged rotatably about the axis of rotation 67 relative to the segment66 via a coupling gear mechanism not visible in FIG. 3. This couplinggear mechanism, too, is drivable via a drive unit connected to thiscoupling gear mechanism so that when this drive unit is activated, thecoupling unit 100 is rotated about the axis of rotation 67. Here, thedrive units of the coupling gear mechanisms are driven such that thelongitudinal axis 510 of the instrument shaft 512 is pivoted about apivot point 69 fixed in space when the manipulator arm 16 and itssegments are moved so that the longitudinal axis 510 of the instrumentshaft 512 inserted into a patient preferably through a trocar during asurgery is then rotated about the pivot point 69 so that it isguaranteed that by a movement of the instrument 500 only a slight stresson the patient at the entrance point of the instrument 500 into thepatient is exerted and in particular an injury of the patient at thepoint of entering of the instrument shaft 512 is prevented.

In FIG. 4, a further perspective illustration of the arrangementaccording to FIG. 3 is shown, wherein the sections 62, 64, 66 of thetelescopic arrangement 60 are illustrated in a retracted state incontrast to FIG. 3, as a result whereof the instrument unit 300 has beendisplaced in the direction of the longitudinal axis 510 of theinstrument shaft 512 to the proximal end of the surgical instrument 500.Thus, by retracting the telescopic arrangement 60, the instrument unit300 has been displaced in the direction of the proximal end of theinstrument 500 along the longitudinal axis 510 of the instrument 500. Indoing so, however, the position of the pivot point 69 has remainedunchanged. Also given a rotation of the segments 56, 58, 60 about theaxis of rotation 57, the pivot point 69 is maintained unchanged in itsposition in space by a corresponding drive of the drive units of thecoupling gear mechanisms 59, in that a corresponding rotation of thesegment 60 about the axis of rotation 61 and of the coupling unit 100about the axis of rotation 67 takes place. Further, a virtual axis ofrotation (not illustrated) which is parallel to the axes of rotation 61,67 and orthogonal to the axis of rotation 57 and has been generated by acorresponding drive of the coupling gear mechanisms extends through thepivot point 69.

In the pivot point 69, the axis of rotation 57 of the segment 56designed as an articulated arm and the longitudinal axis 510 of theinstrument 500 intersect. The pivot point 69 is also referred to aspivotal point.

FIG. 5 shows the coupling unit 100, the sterile lock 200 as well as theinstrument unit 300 with the sterile unit 400 and the surgicalinstrument 500 having an end effector 514 prior to the connection of thesterile lock 200 to the coupling unit 100 and prior to the subsequentjoining of the sterile unit 400 and the sterile lock 200. The flexiblesterile cover 38 designed as a sterile foil is firmly connected to thesterile lock 200 along a circumferential connecting rim 202 of thesterile lock via a suitable connection, such as a clamping, adhesiveand/or welding connection so that the sterile foil 38 forms togetherwith the sterile lock 200 a closed sterile covering around thenon-sterile elements 16, 100 to be shielded from the sterile area 39, asalso shown in FIGS. 1, 3 and 4. For a better illustration, only a detailof the sterile foil 38 around the sterile lock 200 is illustrated inFIG. 5. In subsequent Figures, the sterile foil 38 is sometimes notshown.

For coupling the sterile unit 400 to the coupling unit 100 the sterilelock 200 is arranged between the sterile unit 400 and the coupling unit100 and, in the coupled state of the sterile unit 400 to the couplingunit 100, it allows a direct coupling of a first transmitting means 102of the coupling unit 100 and of a second transmitting means of thesterile unit 400. The second transmitting means is identified with thereference sign 406 in FIG. 15.

In the present embodiment, both mechanical energy and electrical energyis transmitted between the coupling unit 100 and the sterile unit 400 bymeans of the first transmitting means 102. For this, the firsttransmitting means 102 of the coupling unit 100 has at least fourmechanical drive elements 110 to 116 and the second transmitting means406 of the sterile unit 400 has four driven elements 412 to 418illustrated in FIG. 15 which are complementary to the drive elements 110to 116. Further, the first transmitting means 102 has an electricaltransmitting element 104 with two electrical contacts 106, 108 and thesecond transmitting means 406 has an electrical transmitting elementthat is complementary to the electrical transmitting element 104 of thefirst transmitting means 102. The complementary electrical transmittingelement comprises two electrical contacts 422, 423 illustrated in FIG.11.

In other embodiments, the first and second transmitting means can alsocomprise more or less drive elements, driven elements and electricaltransmitting elements, which transmit mechanical and/or electricalenergy by direct coupling. A coupling of the transmitting means in whichno further transmitting elements are provided between the firsttransmitting means and the second transmitting means for a transmissionof mechanical and/or electrical energy and/or optical beams is regardedas a direct coupling, wherein in particular no electrical, mechanical oroptical transmitting elements are provided in a sterile barrier, such asthe sterile lock 200, arranged between the coupling unit 100 and thesterile unit 400. The coupling unit 100 further has an RFID read andwrite unit 121 by means of which an RFID transponder 494 of the sterileunit 400 is readable and/or writable.

FIG. 6 shows a schematic perspective illustration of the coupling unit100 of the manipulator arm 16. The first transmitting means 102 of thecoupling unit 100 has an electrical transmitting element 104 with twoelectrical contacts 106, 108, an optical transmitting means 109 fortransmitting light and/or optical signals, a first translatory driveelement 110 and a second translatory drive element 112, each of whichfor transmitting a translatory movement, as well as a first rotatorydrive element 114 and a second rotatory drive element 116 fortransmitting a rotary motion. The first and the second translatory driveelement 110, 112 are each designed as a linear lift fork and the firstand the second rotatory drive element 114, 116 are designed as drivepinions with end-side teeth. Further, the coupling unit 100 has a firstcoupling sensor 118 arranged in a recess and detecting a first detectionelement formed by a first detection pin projecting from the sterile unit400 when the sterile lock 200 is correctly coupled to the coupling unit100 and when the sterile unit 400 is correctly coupled to the sterilelock 200. In this case, a first detection pin of the sterile unit 400projects into the recess in which the first coupling sensor 118 isarranged so that it detects the presence of the first detection pinserving as a first detection element. The first detection pin is shownin FIG. 15 and is identified with the reference sign 426 therein.

The coupling unit 100 has a second coupling sensor 120 which is arrangedlaterally next to the drive elements 112, 114 in a further recess, ascan be seen more clearly in FIG. 5. The second coupling sensor 120detects a second detection element formed by a second detection pin ofthe sterile unit 400 when both the coupling unit 100 is correctlycoupled to the sterile lock 200 and the sterile lock 200 is correctlycoupled to the sterile unit 400. The second detection pin is shown inFIG. 11 and identified therein with the reference sign 428. Thus, it isreliably determined by means of the coupling sensors 118, 120 whetherthe sterile unit 400 is correctly coupled to the coupling unit 100 sothat a direct transmission between the first transmitting means 102 ofthe coupling unit 100 and the second transmitting means of the sterileunit 400 is possible. For connecting the coupling unit 100 to thesterile lock 200, the coupling unit 100 has opposite guiding grooves122, 124 into which the guiding pins 204, 206 of the sterile lock 200are inserted until they have reached the front end 123, 125 of therespective guiding groove 122, 124, as shown in FIG. 10. At a first endof the sterile lock 200, the guiding pins 204, 206 project outward onopposite sides, as can be seen in FIGS. 5 and 10. Thereafter, theopposite second end of the sterile lock 200 is pushed downward so thatthe sterile lock 200 is rotated about an axis of rotation runningthrough the guiding pins 204, 206 until a snap-in nose 126 of a snap-inelement 128 engages with a complementary snap-in area of the sterilelock 200.

FIG. 7 shows a longitudinal section through the coupling unit 100. Theunlocking button 128 is swivel-mounted about an axis of rotation 130 andis held in its snap-in position shown in FIG. 7 by a spring 132. Fordisconnecting the snap-in connection, an unlocking button 134 of thesnap-in element 128 is pressed by a finger so that a spring 132 istensioned and the snap-in element 128 together with the snap-in nose 126is rotated in the direction of the arrow P0 so that the snap-in nose 126is disengaged from the complementary snap-in element of the sterile lock200. As a result, the second end of the sterile lock 200 previouslyengaged with the snap-in nose 126 can be pivoted out of the couplingunit 100. After this second end of the sterile lock 200 has been pivotedout of the coupling unit 100, the sterile lock 200 can be completelyseparated from the coupling unit 100 in that the sterile lock 200 ispulled out of the guiding grooves 122, 124 along the latter togetherwith the guiding pins 204, 206 engaged with the guiding grooves 122, 124until the guiding elements 204, 206 are no longer engaged with theguiding grooves 122, 124. Between the guiding grooves 122, 124 and thesnap-in element 128 a receiving area formed by a corresponding recess inthe housing of the coupling unit 100 is provided, which in the presentembodiment surrounds the sterile lock 200 on three sides and at least inpart on the bottom side.

FIG. 8 shows a perspective view of the sterile lock 200 with closed lockflaps 208, 210. FIG. 9 shows a perspective view of the sterile lock 200with open lock flaps 208, 210. The sterile lock 200 has a bottom 212 inwhich two openings 214, 216 are provided which can be covered by meansof the lock flaps 208, 210. The lock flaps 208, 210 are pivotallyconnected to the bottom 212 via hinges. By means of these hinges thelock flaps 208, 210 are pivotable from the closed state shown in FIG. 8into the open state shown in FIG. 9. In the open state of the lock flaps208, 210 a direct coupling of the first transmitting means 102 of thecoupling unit 100 with the second transmitting means of the sterile unit400 can be accomplished.

The sterile lock 200 further has two side walls 218, 220, a front endwall 222 and a rear end wall 224. On the outsides of the side walls 218,220 and the end walls 222, 224 the circumferential edge 202 is formedwith which, as already described in connection with FIG. 5, the sterilefoil of the sterile cover 38 is connected in a suitable manner.

On the inside of the front end wall 222 two guiding and unlocking webs228, 230 are firmly arranged on each side next to a V-shaped recess 226of the end wall 222, which webs serve as unlocking elements forunlocking the sterile flaps of the sterile unit 400 when connecting thesterile lock 200 to the sterile unit 400, as will still be described inmore detail in the following.

In the bottom 212 of the sterile lock 200, a first detection window 232and a second detection window 234, each in the form of a through hole,are provided, through which the already mentioned detection elements426, 428 of the sterile unit 400 are passed so that they can be detectedby the first coupling sensor 118 and by the second coupling sensor 120of the coupling unit 100.

At the front and rear end of the lock flaps 208, 210, one guiding bead236 to 242 each is provided. The front guiding beads 236, 238 have nofunction. In the closed state of the lock flaps 208, 210, the tines 246,248 of a guiding fork 244 engage with the rear guiding beads 240, 242.The guiding fork 244 is pushed into its upper position shown in FIG. 8by means of a spring and closes the lock flaps 208, 210 by way ofengagement of its tines 246, 248 into the guiding beads 240, 242 andkeeps them in their closed position. As a result of the engagement ofthe fork tines 246, 248, the lock flaps 208, 210 cannot be pushed apartso that the non-sterile transmitting means 102 of the coupling unit 100is reliably covered when the lock flaps 208, 210 are closed and thenon-sterile elements of the coupling unit 100 are reliably shielded fromthe sterile area 39.

The lock flaps 208, 210 are identical in construction so that for aboth-sided use each time one guiding bead 236 to 242 is provided on bothfront ends of the lock flaps 208, 210. In other embodiments, the lockflaps 208, 210 can also be formed differently and have a guiding bead240, 242 on one side only into which the tines 246, 248 of the guidingfork 244 engage.

In the side walls 218, 220, one snap-in bead 250, 252 each is providedinto which a snap-in element of the sterile unit 400 engages whenconnecting the sterile lock 200 to the sterile unit 400. At the rear endwall 224 of the sterile lock 200 a guiding web 254 is provided whichengages into a guiding groove 452 of the sterile unit 400 whenconnecting the sterile lock 200 to the sterile unit 400, as shown inFIG. 16.

FIG. 10 shows a partial sectional side view of the sterile lock 200. Onthe outside of the rear end wall 224 of the sterile lock 200 a snap-innose 255 is formed into which the snap-in nose 126 of the snap-inelement 128 of the coupling unit 100 engages when the coupling unit 100is connected to the sterile lock 200.

For a correct positioning of the sterile lock 200 in the receiving areaof the coupling unit 100, two positioning elements 256, 257 projectingfrom the bottom are provided which engage with corresponding openings136, 138 in the bottom of the receiving area of the coupling unit 100.The positioning elements 256, 257 are chamfered or alternativelyconical, so that they can easily be inserted into the openings 136, 138of the coupling unit 100 shown in FIG. 7.

The detection windows 232 and 234 are each covered with a foil 262, 264which still shields the detection elements 426, 428 of the sterile unit400 in a sterile manner even when these project through the detectionwindows 232, 234 up into the recesses of the sensors 118, 120 of thecoupling unit 100. In doing so, the foil 262, 264 is elastically and/orplastically deformed and does not tear apart.

FIG. 11 shows a sectional illustration of the sterile lock 200 accordingto FIG. 10 along the sectional line A-A. In this Figure, the axis ofrotation about which the lock flap 110 is pivoted from the closed intothe open state and vice versa is identified with D1 and the axis ofrotation about which the lock flap 208 is pivoted is identified with D2.

FIG. 12 shows a sectional illustration of the sterile lock 200 accordingto FIG. 10 along the sectional line B-B and FIG. 13 shows a sectionalillustration of the sterile lock 200 according to FIG. 10 along thesectional line C-C. As can be seen from FIGS. 8 to 13, the side walls218, 220, the end walls 222, 224 and the bottom 218 form a housingtrough into which the sterile unit 400 is insertable at least in partfor connecting the sterile unit 400 to the coupling unit 100. Thehousing trough thus generally serves as a first connecting area 266 ofthe sterile lock 200. The outside of the sterile lock 200 serves as asecond connecting area 268 with which the sterile lock 200 isconnectable to the coupling unit 100.

As can be seen in FIG. 13, the front ends of the tines 246, 248 of theguiding fork 244 engage with the guiding beads 240, 242. The facing sidewalls of the guiding beads 240, 242 form together with the front ends ofthe tines 246, 248 of the guiding fork 244 a slotted guide by which thelock flaps 208, 210 are closed when the front ends of the tines 246, 248of the fork 244 are pivoted upward.

FIG. 14 shows a detailed view with partially open lock flaps 208, 210and the tines 246, 248 of the guiding fork 244 engaged with the guidingbeads 240, 242. In the horizontal illustration of the sterile lock 200shown in FIGS. 8 to 14, the guiding fork 244 is pivoted upward by meansof a guiding fork spring 258 about an axis of rotation D3 formed by aguiding pin 260 mounted in the rear end wall 224 so that the lock flaps208, 210 are closed by means of the spring force of the guiding forkspring 258 and are held in a closed position. The guiding pin 260 servesto guide and mount the spring 258 as well as to mount the guiding fork244. When inserting the sterile unit 400 into the sterile lock 200, thenthe guiding fork 244 is pivoted downward against the spring force of theguiding fork spring 258 so that the sterile flaps 208, 210 are pivotedfrom the closed state into the open state by engaging elements providedon the sterile unit 400.

FIG. 15 shows a perspective illustration of the instrument unit 300 withthe sterile unit 400 and the surgical instrument 500. At the proximalend of the rotatable outer instrument shaft 512 the bendable androtatable end effector 514 with actuatable gripping arms 516, 518 isarranged. The movements of the end effector 514 can be performed bymeans of the drive elements 110 to 116 of the coupling unit 100 and thedriven elements 408 to 414 of the sterile unit 400 when the sterile unit400 is connected to the coupling unit 100 via the sterile lock 200. Thesterile unit 400 has sterile flaps 402, 404, which are shown in an openstate in FIG. 15 and in a closed state in FIG. 16. Inside the sterileunit 400, the second transmitting means is arranged which is visiblewhen the sterile flaps 402, 404 are open and is identified with thereference sign 406. When coupled to the coupling unit, the secondtransmitting means 406 comprises a first translationally driven element408 engaged with the first translatory drive element 110 and a secondtranslationally driven element 410 engaged with the second translatorydrive element 112 of the coupling unit 100, each time for transmitting atranslation. Further, a first rotationally driven element 412 couplableto the first rotatory drive element 114 of the coupling unit 100 as wellas a second rotationally driven element 414 engaged with the secondrotatory drive element 116 of the coupling unit 100 are provided fortransmitting a rotary motion each. In the surgical instrument 500connected to the coupling unit 400, the end effector 514 is pivotedabout the tilt axis D4 in the arrow direction P1 by up to 90° when thesecond translationally driven element 410 of the sterile unit 400 ismoved by the second translatory drive element 112 of the coupling unit100 in the direction of the arrow P2. When moving the firsttranslationally driven element 408 in the direction of the arrow P3, thegripping arms 516, 518 of the end effector 514 are moved apart and movedtowards each other in opposite directions. When driving the firstrotationally driven element 412 of the sterile unit 400 with the aid ofthe first rotatory drive element 114 of the coupling unit 100, the endeffector 514 can be rotated independent of the instrument shaft 512. Bymeans of the second rotationally driven element 414, given a couplingand a drive by means of the second rotatory drive element 116 of thecoupling unit 100, a rotation of the instrument shaft 512 about itslongitudinal axis 510 can be produced to rotate the position of the tiltaxis D4 of the end effector 514 about the axis of rotation 510 of theouter instrument shaft 512 without the end effector 514 itself beingrotated.

Further, a first spring 416 is provided which pushes the firsttranslationally driven element 408 of the sterile unit 400 opposite tothe direction of the arrow P3 into its end position. Further, a secondspring 418 is provided which pushes the second translationally drivenelement 410 of the sterile unit 400 opposite to the direction of thearrow P2 into its end position. Further, the sterile unit 400 has abearing 420 for rotatably mounting the outer instrument shaft 512 in thesterile unit 400. As an alternative to the surgical instrument 500, alsoother instruments, such as a pair of scissors, a needle holder, opticalinstruments, rinsing units, aspiration units, instruments ofhigh-frequency surgery and other instruments used in operations, inparticular in laparoscopic surgeries can be coupled to the sterile unit400, wherein the second transmitting means 406 are designed for theimplementation of the corresponding functions.

According to the embodiment, the second transmitting means 406 furthercomprises an electrical transmitting element with a first electricalcontact 422 designed as a slip ring and a second electrical contact 423designed as a slip ring, which, when coupling the sterile unit 400 tothe coupling unit 100 via the sterile lock 200, establish an electricalconnection with the electrical contacts 106, 108 of the coupling unit100 for transmitting high-frequency electrical energy for high-frequencysurgery. In other embodiments, also no electrical transmitting means maybe provided.

The sterile unit 400 has two projecting cams 415, 417 which uponinsertion of the sterile unit 400 into the sterile lock 200 push theunlocked sterile flaps 208, 210 apart at least until the cams 415, 417are arranged between the sterile flaps 208, 210. Upon further insertionof the sterile unit 400 into the sterile lock 200, wedge-shaped engagingelements 456 to 462 of the sterile unit 400 push the sterile flaps 208,210 further apart until they are arranged in their open position shownin FIG. 9.

The bottom plate 401 of the sterile unit 400 facing upward in FIGS. 15and 16 has, as already mentioned, two detection elements 426, 428 formedas projecting detection pins. When coupling the sterile unit 400 to thecoupling unit 100 with the sterile lock 200 arranged between the sterileunit 400 and the coupling unit 100, the detection element 426 projectsthrough the first detection window 232 of the sterile lock 200 into therecess of the first coupling sensor 118 of the coupling unit 100 and thesecond detection element 428 projects through the second detectionwindow 234 into the recess of the second coupling sensor 120 of thecoupling unit 100. When the detections elements 426, 428 are detected bymeans of the coupling sensors 118, 120, a correct coupling of thesterile lock 200 to the coupling unit 100 and of the sterile unit 400 tothe sterile lock 200 can be detected so that only after a detection ofthe detection elements 426, 428 with the aid of the coupling sensors118, 120 a drive of the transmitting elements 110 to 116 is enabled by acontrol unit. Further, the transmission of high-frequency energy is onlyenabled after the correct detection of the detection elements 426, 428by means of the coupling sensors 118, 120 via the transmitting elements106, 108.

Further, the sterile unit 400 has two snap-in elements 434, 436 arrangedon opposite side walls 430, 432, which snap-in elements are actuatableby means of an actuating element 438, 440 projecting from the side wall430, 432. The snap-in elements 434, 436 engage with the snap-in beads250, 252 provided in the side walls 218, 220 of the sterile lock 200when the sterile unit 400 is correctly connected to the sterile lock200.

The front end wall 442 of the sterile unit 400 has two grooves 444, 446into which the guiding and unlocking webs 228, 230 of the sterile lock200 are inserted when connecting the sterile unit 400 to the sterilelock 200 and, in doing so, unlock the sterile flaps 402, 404, as willstill be explained in more detail in the following.

Further, the guiding web 254 of the sterile lock 200 engages into theguiding groove 452 present on the rear end side 450 of the sterile unit400. At the lower end of the guiding groove 452, an actuating web 454projects outward from the bottom plate 401 and pushes the guiding fork244 downward when inserting the sterile unit 400 into the sterile lock200 and thus unlocks the lock of the lock flaps 208, 210 by the guidingfork 244.

FIG. 17 shows a side view of the sterile unit 400 with a part of theinstrument shaft 512 of the surgical instrument 500. FIG. 18 shows asectional view of the sterile unit according to FIG. 17 along thesectional line E-E. As can be seen from this sectional illustration, thesterile flap 402 is engaged with a guiding flap 464 provided in thesterile unit 400. The sterile flap 404 is engaged with a guiding flap464 arranged inside the sterile unit 400. For opening the sterile flap402, the sterile flap is arranged pivotally about the axis of rotationD5 and the guiding flap 464 is arranged pivotally about the axis ofrotation D6. For opening the sterile flap 404, this sterile flap isarranged pivotally about the axis of rotation D7 and the guiding flap464 is arranged pivotally about the axis of rotation D8. In the closedstate, the sterile flaps 402, 404 are locked by means of the guidingflaps 464, 466 and are unlocked for opening the sterile flaps 402, 404,as will still be explained in more detail in the following in connectionwith FIGS. 22 to 28.

In FIG. 19, a sectional view of the sterile unit 400 according to FIG.17 along the sectional line F-F is shown. In FIG. 19, a spring 468 isvisible, by means of which the actuating elements 438, 440 and togethertherewith the snap-in noses 434, 436 are pressed outward so that thesnap-in noses 434, 436 are pressed into the snap-in beads 250, 252 ofthe sterile lock 200 when the sterile unit 400 has correctly beeninserted into the sterile lock 200.

FIG. 20 shows a detail of a bottom view of the instrument unit 300 withclosed sterile flaps 402, 404 of the sterile unit 400. In thisillustration, an unlocking pin 470 of the guiding flap 464 and anunlocking pin 472 of the guiding flap 466 are visible. The unlocking pin470 projects into the guiding and unlocking groove 444 and the unlockingpin 472 projects into the unlocking and guiding groove 446. Whenconnecting the sterile unit 400 to the sterile lock 200, the guiding andunlocking webs 228, 230 of the sterile lock 200 are inserted into theguiding grooves 444, 446 and press the unlocking pins 470, 472 from thelocked position shown in FIG. 20 into the unlocked position shown inFIG. 21. In FIG. 21, the sterile flaps 202, 204 and the guiding flaps464, 466 are illustrated in an unlocked and open state.

FIG. 22 shows a top view of the sterile flap system of the sterile unit400 with closed sterile flaps 402, 404 and closed and locked guidingflaps 464, 466. The sterile flap system has in addition to the sterileflaps 402, 404 and the guiding flaps 464, 466 a spring 474 which isbiased and keeps the guiding flap 466 and the sterile flap 404 engagedwith the guiding flap 466 in the closed state shown in FIG. 22. Afterunlocking the guiding flap 466, the guiding flap 466 and the sterileflap 404 can be opened against the spring force of the spring 474. Thesterile flap system further has a spring 476 which is biased and keepsthe guiding flap 464 and the sterile flap 402 in their closed state. Theguiding flap 464 and the sterile flap 402 can be opened against thespring force of the spring 476 when the guiding flap 464 has beenunlocked. For unlocking the guiding flaps 464, 466, the unlocking pins470, 472 are moved by the guiding and unlocking webs 228, 230 in thedirection of the arrows P4, P5 within their little clearance up to theposition illustrated in FIG. 24. In doing so, the sterile flaps 402, 404are not or only slightly moved in the direction of the arrows P4, P5 sothat for unlocking a relative movement of the guiding flaps 464, 466relative to the sterile flaps 402, 404 in the direction of the arrowsP4, P5 takes place. FIG. 23 is a sectional illustration of the sterileflap system according to FIG. 22 along the sectional line G-G withclosed guiding flaps 464, 466 and closed sterile flaps 402, 404.

In FIG. 24, the guiding flaps 464, 466 and the sterile flaps 402, 404are illustrated in their open position. FIG. 25 is a sectionalillustration of the sterile flap system according to FIG. 24 along thesectional line H-H with open guiding flaps 464, 466 and open sterileflaps 402, 404.

FIG. 26 shows a perspective detailed view of the sterile flap 404 andthe sterile flap 404 engaged therewith in a closed locked position. Inaddition, the spring 474 not illustrated in FIG. 26 presses the guidingflap 466 opposite to the arrow P5 into its locked position and thespring 474 presses the guiding flap 466 additionally opposite to thedirection of the arrow P4 into its locked position so that for unlockingthe guiding flaps 464, 466 the unlocking pins 470, 472 are moved againstthe spring force of the springs 474, 476 in the direction of the arrowsP4, P5.

On the side facing the guiding flap 466, the sterile flap 404 has sevenguiding and locking grooves 478 to 488 into each of which one guidingand locking web 479 to 489 of the guiding flap 466 engages. The guidingand locking webs 479 to 489 are arranged on the side of the guiding flap466 facing the sterile flap 404. The sterile flap 404 and the guidingflap 466 are illustrated in their locked position in FIG. 26. In thislocked state, the guiding and locking webs 479 to 489 are each arrangedbehind a projection of the guiding and locking grooves 478 to 488 sothat, as a result thereof, a rotation of the sterile flap 404 and of theguiding flap 466 about the axes of rotation D5, D6 in the direction ofthe arrows P6 and P7 is prevented. For unlocking the guiding flap 466,this guiding flap is moved in the direction of the arrow P5 by means ofthe unlocking pin 472 so that the guiding and locking webs 479 to 489are moved out of the projections of the guiding and locking grooves 478to 488 so that the guiding flap 466 and the sterile flap 404 can bemoved about the axes of rotation D7, D8 in the direction of the arrowsP6 and P7.

The sterile flap arrangement of the sterile flap 402 and of the guidingflap 464 are mirror-symmetrically with respect to the flap arrangementof the sterile flap 404 and the guiding flap 466 shown in FIG. 26 sothat their locking and unlocking is accomplished in the same manner asdescribed for the sterile flap 404 and the guiding flap 466.

FIG. 27 shows a top view of the guiding flap 466 and the lock flap 404in a partial sectional illustration in the closed and locked state. Inthe sectional area, the guiding and locking groove 480 of the guidingflap 466 is visible.

The guiding and locking groove 480 is arranged behind the projection 490of the guiding and locking groove 480 serving as a blocking nose so thatin the case of a torque acting on the guiding flap 466 and/or on thesterile flap 404 for a rotary motion of the guiding flap 466 in thedirection of the arrow P7 or the sterile flap 404 in the direction ofthe arrow P6, the guiding and locking element 480 would be pressedagainst the blocking nose 490. As a result, neither a rotation of theguiding flap 466 about the axis of rotation D8 in the direction of thearrow P7 nor a rotation of the sterile flap 404 about the axis ofrotation D7 in the direction of the arrow P6 is possible. Only after theguiding flap 466 has been moved in the direction of the arrow P5, asillustrated in FIG. 28, the guiding flap 466 is rotatable about the axisof rotation D8 in the direction of the arrow P7 and the sterile flap 404is rotatable about the axis of rotation D7 in the direction of the arrowP6. Further, in doing so, the guiding flap 466 is moved in the arrowdirection P8 relative to the sterile flap 404. By moving the guidingflap 466 in the direction of the arrow P5, the guiding flap 466 has beenmoved relative to the sterile flap 404 so that the guiding and lockingweb 481 is no longer arranged behind the projection 490 but in the areaof the guiding groove 480 open to the outside. As a result, the sterileflap 404 can be rotated in the direction of the arrow P6 and the guidingflap 466 can be rotated in the direction of the arrow P7 so that thesterile flap 404 and the guiding flap 466 can be moved into their openposition, respectively. The further guiding and locking webs 479 to 489are moved together with the guiding and locking web 481 out of theblocking area of the respective guiding and locking groove 478 to 488formed by the projection, as this has been explained with respect to theguiding and locking web 481 and the guiding and locking groove 480.

In FIG. 29, the guiding flap 466 and the sterile flap 404 areillustrated in their open position, in which the guiding and lockingwebs 479 to 489 project partially from the guiding ad locking grooves478 to 488 by way of the relative movement in the arrow direction P8.

FIG. 30 shows a partial sectional illustration of an arrangement with asterile lock 200 and a sterile unit 400 connected to the sterile lock200. FIG. 31 shows a sectional illustration of the arrangement accordingto FIG. 30 along the sectional line I-I, FIG. 32 a sectionalillustration of the arrangement according to FIG. 30 along the sectionalline J-J, FIG. 33 a sectional illustration of the arrangement accordingto FIG. 30 along the sectional line K-K and FIG. 34 a sectionalillustration of the arrangement according to FIG. 30 along the sectionalline L-L. As can be seen in FIG. 31, the sterile unit 400 has an RFIDtransponder 494 in which preferably at least one unambiguousidentification of the sterile unit 400 and preferably information aboutthe surgical instrument 500 coupled with the sterile unit 400 arestored. In addition, further information such as information on themanufacturer of the sterile unit 400, batch information, durabilityinformation, can be stored preferably in an area of the RFID transponder494 that cannot be overwritten. In a memory area of the RFID transponder494 that can preferably be written only once information on the firstuse of the sterile unit 400, in particular the point in time of thefirst use and/or an unambiguous surgery identification of the surgery inwhich the first use of the sterile unit 400 took place can be stored, sothat by way of this information it can be prevented that the sterileunit 400 is used in a further surgery, in particular in a furtherpatient. The identification of the RFID transponder 494 and/or theinformation stored in the RFID transponder 494 can be read by means ofthe RFID read and write unit 121 of the coupling unit 100 and ifnecessary information in the form of data can be stored in the RFIDtransponder 494.

FIG. 32 shows that in the case of a connection of the sterile unit 400to the sterile lock 200 both the lock flaps 208, 210 and the guidingflaps 464, 466 and the sterile flaps 402, 404 are open so that thesecond transmitting means 406 of the sterile unit 400 can be broughtinto direct contact with the first transmitting means 102 through theflaps 208, 210, 402, 404, 464, 466. In particular, both a directelectrical connection between the electrical contact elements 106, 108of the coupling unit 100 and the electrical contact elements 422, 423 ofthe sterile unit 400 can be established and a direct engagement of themechanical transmitting means 110 to 116 of the coupling unit 100 withthe transmitting elements 408 to 414 of the sterile unit 400 can beaccomplished. Thus, no additional electrical and/or mechanicaltransmitting elements between the coupling unit 100 and the sterile unit400 are required. This is both more cost-efficient and less susceptibleto failure than the provision of additional transmitting elements, inparticular mechanical transmitting elements, between the coupling unit100 and the sterile unit 400, as for example used in the prior art.

As can be well seen in FIG. 32, the sterile flaps 208, 210 have beenpushed apart by means of the V-shaped elements 456 to 462 up into theirposition shown in FIG. 32, after they have been pushed apart by means ofthe cams 415, 417 already so far that the V-shaped elements 456 to 462engage with the opening gap created in this way and the push the lockflaps 208, 210 as well as the sterile flaps 402, 404 together with theguiding flaps 464, 466 each time in their open position.

In the open state, the sterile outside of the sterile flap 402 and thesterile outside of the lock flap 208 are arranged opposite to eachother. In the same way, the sterile outside of the sterile flap 404 andthe sterile outside of the lock flap 210 are arranged opposite to eachother so that even in the case of a direct contact of the sterile flap402 with the lock flap 208 and a direct contact of the sterile flap 404with the lock flap 210, respectively, neither a contamination of thelock flaps 208, 210 nor a contamination of the sterile flaps 402, 404takes place.

Thus, only sterile non-contaminated areas of the sterile lock 200 comeinto contact with sterile non-contaminated areas of the sterile unit 400so that after a separation of the sterile unit 400 from the sterile lock200 there is no risk of a contamination of the sterile area 39.

In FIG. 34 it is shown how the snap-in elements 434, 436 of the sterileunit 400 engage with the snap-in beads 250, 252 of the sterile lock 200when the sterile unit 400 is correctly connected to the sterile lock200. Further, it can be seen in FIG. 34 how the detection element 426projects through the first detection window 232, the detection element426 projecting into the recess of the first sensor 118 of the couplingunit 100 when the sterile lock 200 is connected to the coupling unit 100so that the sensor detects the detection element 426. Further, in FIG.34, the foil 162 is illustrated which is elastically and/or plasticallydeformed by the detection element 426 and thus covers the detectionelement 426 in a sterile manner.

FIG. 35 shows elements of the sterile flap system with the sterile flaps402, 404 and the guiding flaps 464, 466 and elements of the lock flapsystem of the sterile lock 200 with the lock flaps 208, 210. As alreadyexplained, the tines 246, 248 of the guiding fork 244 engage with theguiding beads 240, 242 in the closed state of the lock flaps 208, 210 sothat via this engagement there is a positive connection which preventsthat the lock flaps 208, 210 are pushed open. In the position of theguiding fork 244 shown in FIG. 35, its tines 246, 248 are no longerengaged with the guiding beads 240, 242 of the lock flaps 208, 210 sothat these can be opened further by the V-shaped engaging elements 456to 462 of the sterile unit 400. In FIG. 35, the lock flaps 208, 210 andthe guiding flaps 464, 466 as well as the sterile flaps 202, 204 areillustrated in a position before the lock flaps 208, 210 are openedfurther by means of the V-shaped engaging elements 456 to 462. In doingso, both the lock flaps 208, 210 and the guiding flaps 464, 466 and thesterile flaps 402, 404 are opened further up to the position shown inFIGS. 33, 34. In order to illustrate the differences between the lockedposition and the unlocked position of the unlocking pins 470, 472, thelocking pin 470 is illustrated in its locked position and the unlockingpin 472 is illustrated in its unlocked position in FIG. 35. Here, it hasto be taken into account that the guiding flap 464 and the sterile flap402, despite the arrangement of the unlocking pin 470 in the lockedposition, have been pivoted about their axes of rotation D5, D6 up tothe partially open position shown in FIG. 35, although this would not bepossible in case of an actual locking.

In FIG. 36, a side view of the arrangement according to FIGS. 30 to 35is shown and in FIG. 37 a sectional illustration of a portion of thearrangement according to FIG. 36 along the sectional line M-M is shown.In FIG. 38, a sectional illustration of the arrangement according toFIG. 36 along the sectional line N-N is shown.

FIG. 39 shows a top view of an arrangement with the coupling unit 100,the sterile lock 200 and the instrument unit 300 comprising the sterileunit 400 and the sterile surgical instrument 500. FIG. 40 shows asectional illustration of the arrangement according to FIG. 39 along thesectional line O-O in a first position immediately before connecting thesterile unit 400 of the instrument unit 300 to the sterile lock 200already coupled to the coupling unit 100. FIG. 41 shows a sectionalillustration of the arrangement according to FIG. 39 along the sectionalline O-O in a second position for connecting the sterile unit 400 of theinstrument unit 300 to the sterile lock 200 already coupled to thecoupling unit 100. FIG. 42 shows a sectional illustration of thearrangement according to FIG. 39 along the sectional line O-O in a thirdposition in which the sterile unit 400 of the instrument unit 300 isconnected to the sterile lock 200 coupled to the coupling unit 100 sothat the first transmitting means 102 of the coupling unit 100 areengaged with the transmitting elements of the second transmitting means406 for direct coupling.

In the position shown in FIG. 40, the guiding flaps 464, 466 have beenmoved by the insertion of the guiding and unlocking webs 228, 230 intothe grooves 444, 446 and thus have already been moved along their axisof rotation D6, D8 in the direction of the arrows P4, P5 from theirlocked position into their unlocked position so that the sterile flaps402, 404 together with the guiding flaps 464, 466 have been pushed openby a movement of the sterile unit 400 in the direction of the arrow P10and the contact of the sterile flaps 402, 404 with the lock flaps 208,210 caused thereby. As a result, the sterile unit 400 gets deeper intothe receiving area of the sterile lock 200 provided for receiving thesterile unit 400 so that the actuating web 454 comes into engagementwith the guiding fork 244 and pivots the same against the spring forceof the guiding fork spring 258. As a result, the tines 246, 248 of theguiding fork 244 are engaged with the guiding beads 240, 242 such thatthe lock flaps 208, 210 can be pushed apart by the cams 415, 417 andthus be opened. When the sterile unit 400 is further moved in thedirection of the arrow P10, the V-shaped engaging elements 458 to 462come into engagement with the lock flaps 208, 210 and push these and thesterile flaps 402, 404 together with the guiding flaps 464, 466 furtheroutward into their fully open position shown in FIG. 42. By the contactof the lock flaps 208, 210 with the sterile flaps 402, 404, these areopened further together with the guiding flaps 464, 466 until all flaps208, 210, 402, 404, 464, 466 are arranged in the open position shown inFIG. 42.

In the case of a reversed movement of the sterile unit 400, when thesterile unit 400 is removed from the sterile lock 200, i.e. from theposition shown in FIG. 42 into the position shown in FIG. 40 opposite tothe direction of the arrow P10, a reversed sequence of motion of thesterile, guiding and lock flaps takes place so that these flaps are inparticular closed by the spring force of the springs 474, 476 and thetines 246, 248 of the guiding fork 244 are again engaged with theguiding beads 240, 242 and completely close the lock flaps 208, 210. Bythe positive connection between the fork tines 246, 248 and the guidingbeads 240, 244 caused in this way, the lock flaps 208, 210 are reliablyheld in their closed position so that the lock flaps 208, 210 cannot beopened from outside. Further, the guiding flaps 464, 466 are completelyclosed and moved into their locked position by means of the springs 474,476 when the sterile unit 400 is removed from the sterile lock 200 sothat afterwards these cannot be opened even when an external force isapplied on the sterile flaps 402, 404.

FIG. 43 shows a detail of an instrument unit 1300 with a sterile unit1400 and a surgical instrument 1500 according to a second embodiment. Incontrast to the instrument unit 300, the sterile unit 1400 of theinstrument unit 1300 has no sterile flaps but a jalousie 1410 forcovering the driven elements in a sterile manner. The further structureand the function of the instrument unit 1300 corresponds to thestructure and the function of the instrument unit 300 according to FIGS.1 to 42.

FIG. 44 shows a detail of a sterile covering 1038 with a sterile lock1200 which in contrast to the sterile lock 200 has no sterile flaps buta jalousie 1210 for shielding drive elements of the coupling unit 100 ina sterile manner. The jalousie 1410 of the coupling unit 1400 and thejalousie 1210 of the sterile lock 1200 are opened in a suitable mannerby a mechanical engagement when connecting the sterile unit 1400 to thesterile lock 1200 or the sterile unit 1400 to the sterile lock 200 orthe sterile unit 400 to the sterile lock 1200, respectively.Alternatively, active drive elements, such as one electric motor each,for opening and closing the respective jalousie 1410, 1210 can beprovided.

In FIG. 45, a detail of an instrument unit 2300 with a sterile unit 2400according to a third embodiment is shown. The sterile unit 2400 has noelements for covering the driven elements in a sterile manner so thatthis instrument unit 2400 is immediately removed from the sterile area39 after separation from the sterile lock 200, 1200 or after separationfrom a further sterile lock 2200 shown in FIG. 46.

The sterile cover 2038 shown in FIG. 46 comprises a sterile lock 2200which is couplable to the coupling unit 100 just like the sterile unit200. In contrast to the sterile lock 200, the sterile lock 2200 has nolock flaps but comprises a foil provided with predetermined breakingpoints indicated by means of dotted lines, which foil is torn open alongthe predetermined breaking points when connecting a sterile unit 400,1400, 2400 to the sterile lock 2200 so that a direct coupling of thedrive elements 110 to 116 of the coupling unit 100 with the drivenelements 408 to 414 is easily possible. Preferably, when using thesterile lock 2200, the sterile unit 400, 1400, 2400 is not separatedduring a surgery but only after the surgery has been terminated.

The invention claimed is:
 1. A device for robot-assisted surgerycomprising: at least one non-sterile manipulator arm having a couplingunit which has at least one first transmitting means, at least onesterile unit arranged in a sterile area and having at least one secondtransmitting means, a sterile cover for shielding at least a part of thenon-sterile manipulator arm from the sterile area, wherein the sterilecover comprises a sterile lock with which the coupling unit and thesterile unit are each connectable, the sterile lock having at least onelock flap movable relative to the sterile lock between an open stateuncovering an opening in the sterile lock and a closed state coveringthe opening in the sterile lock and lock and shielding the firsttransmitting means in a sterile manner, so that as the sterile unit isconnected to the sterile lock the at least one lock flap moves from theclosed state into the open state allowing a direct transmission betweenthe first transmitting means and the second transmitting means throughthe opening, and as the sterile unit is separated from the sterile lockthe at least one lock flap moves from the open state into the closedstate wherein the lock flap shields the first transmitting means fromthe sterile area.
 2. The device according to claim 1, characterized inthat the sterile unit has at least one sterile flap which in a closedstate shields the second transmitting means in a sterile manner; so thatwhen connecting the sterile unit to the sterile lock each time amovement of the lock flap and of the sterile flap from the closed stateinto the open state takes place, a direct transmission between the firsttransmitting means and the second transmitting means through an openinguncovered by the lock flap and the sterile flap in the open state ispossible; and so that when separating the sterile unit from the sterilelock, a movement of the lock flap and of the sterile flap each time fromthe open state into the closed state takes place after separation, thelock flap shields the first transmitting means from the sterile area andthe sterile flap shields the second transmitting means from the sterilearea.
 3. The device according to claim 1, characterized in that thefirst transmitting means of the coupling unit comprises at least one ofat least one drive element, at least one first electrical transmittingelement interface, or at least one optical transmitting element, thesecond transmitting means of the sterile unit comprises at least one ofat least one driven element, at least one electrical contact), or atleast one optical transmitting element, and the sterile lock isconnectable to the coupling unit and the sterile unit such that at leastone of the at least one drive element is directly engaged with the atleast one driven element, the first transmitting means is coupled withthe electrical contact, or the optical transmitting element of thecoupling unit is directly coupled with the optical transmitting elementof the sterile unit.
 4. The device according to claim 3 wherein the atleast one optical transmitting element of the coupling unit and the atleast one sterile unit form an optical interface between the couplingunit and the at least one sterile unit.
 5. The device according to claim1, characterized in that the coupling unit is arranged at a proximal endof the non-sterile manipulator arm, the sterile unit forms part of atleast one of a surgical instrument, an endoscope, or a medical device,wherein the sterile unit is arranged at a distal end of at least one ofthe surgical instrument, the endoscope, or the medical device, thecoupling unit is connectable to a first connecting area of the sterilelock, the sterile unit is connectable to a second connecting area of thesterile lock, and the first connecting area and the second connectingarea are arranged on sides of the sterile lock facing away from eachother.
 6. The device according to claim 5, characterized in that thesterile outside of the sterile flap and the sterile outside of the lockflap are arranged opposite to each other when connecting the sterileunit to the second connecting area, when both the sterile flap and thelock flap are open, wherein the sterile outsides of the sterile flap andthe lock flap face each other in the open state.
 7. The device accordingto claim 1, characterized in that the first connecting area of thesterile lock is connectable to the coupling unit via a first releasablesnap-in connection and the second connecting area of the sterile lock isconnectable to the sterile unit via a second releasable snap-inconnection.
 8. The device according to claim 1, characterized in thatthe coupling unit comprises at least one coupling sensor which detectsthe presence of a sterile unit that is connected to the sterile lock,the device has a control unit which only allows a transmission betweenthe first transmitting means and the second transmitting means when asterile unit that is connected to the sterile lock has been detected bymeans of the coupling sensor.
 9. The device according to claim 1,characterized in that the coupling unit has several drive elements asfirst transmitting means, the sterile unit has several driven elements,wherein the drive elements are engaged with the driven elements for amechanical coupling of the coupling unit with the sterile unit when thesterile unit is coupled with the sterile lock and when the coupling unitis coupled with the sterile lock.
 10. The device according to claim 1,characterized in that the lock flap separates the first connecting areafrom the second connecting area, automatically opens when connecting thesterile unit to the second connecting area, and automatically closeswhen separating the sterile unit from the second connecting area. 11.The device according to claim 10, characterized in that the lock flap isautomatically unlocked when connecting the sterile unit to the secondconnecting area and is automatically locked when separating the sterileunit from the second connecting area.
 12. The device according to claim1, characterized in that the sterile unit has at least one sterile flapwhich covers the at least one second transmitting means, automaticallyopens when connecting the sterile unit to the second connecting area,and automatically closes when separating the sterile unit from thesecond connecting area.
 13. The device according to claim 12,characterized in that the sterile flap is automatically unlocked whenconnecting the sterile unit to the second connecting area and isautomatically locked when separating the sterile unit from the secondconnecting area.
 14. An arrangement for robot-assisted surgery,comprising: at least one device according to claim 1, at least onedisplay unit which outputs at least one image of the operating area inreal time, at least one input device for the input of at least one inputcommand, and a control unit which positions the non-sterile manipulatorarm and the sterile unit connected via the sterile lock to the couplingunit of the non-sterile manipulator arm dependent on the input commandby means of at least one drive unit.
 15. The device according to claim 1wherein the coupling unit has at least one electrical contact as thefirst transmitting means and the sterile unit has at least onecomplementary electrical contact as the second transmitting means,wherein the at least one electrical contact of the coupling unit and theat least one complimentary electrical contact of the sterile unitestablish an electrical connection between the coupling unit and thesterile unit for transmitting at least high-frequency electrical energywhen the coupling unit is coupled with the sterile lock and when thesterile unit is coupled with the sterile lock.
 16. A sterile lockcomprising: a first connecting area for connecting the sterile lock to anon-sterile coupling unit, a second connecting area for connecting thesterile lock to a sterile unit arranged in a sterile area, acircumferential third connecting area for connecting the sterile lock toa flexible sterile cover for shielding the sterile area from thenon-sterile elements, wherein the sterile lock has at least one lockflap, movable relative to the sterile lock between a closed state and anopen state, that in the closed state closes an opening between the firstconnecting area and the second connecting area in a sterile manner, andthat in the open state uncovers the opening between the first connectingarea and the second connecting area.
 17. The sterile lock according toclaim 16, configured so that as the sterile lock is connected to thecoupling unit, the lock flap moves from the closed state into the openstate allowing a direct transmission between a first transmitting meansof the coupling unit and a second transmitting means of the sterile unitthrough the opening, and as the sterile unit is separated from thesterile lock the lock flap moves from the open state into the closedstate shielding the first transmitting means from the sterile area, andis locked in the closed state.
 18. A method for robot-assisted surgeryin which a non-sterile manipulator arm is shielded from a sterile areaby means of a sterile cover and a sterile lock integrated in the cover,characterized in that a non-sterile coupling unit of the non-sterilemanipulator arm is connected to a first connecting area of the sterilelock so that in a closed state a lock flap of the sterile lock closes anopening to at least one first transmitting means arranged in thecoupling unit in a sterile manner, a sterile unit arranged in thesterile area is connected to a second connecting area of the sterilelock, wherein the lock flap is automatically opened, wherein the openingconnects the first connecting area to the second connecting area so thata transmission between the first transmitting means of the coupling unitand a second transmitting means of the sterile unit is possible, and thesterile unit is separated from the second connecting area, wherein thelock flap is automatically closed and closes the opening in a sterilemanner.
 19. The method according to claim 18, characterized in that thesterile unit has at least one sterile flap; that the second transmittingmeans is shielded by the sterile flap in its closed state in a sterilemanner; that the lock flap and the sterile flap are each moved from theclosed state into the open state when connecting the sterile unit to thesterile lock so that a direct transmission between the firsttransmitting means and the second transmitting means through an openinguncovered by the lock flap and the sterile flap in the open state ispossible, and that when separating the sterile unit from the sterilelock, the lock flap and the sterile flap are each moved from the openstate into the closed state so that after the separation the firsttransmitting means is shielded from the sterile area by means of thelock flap and the second transmitting means is shielded from the sterilearea by means of the sterile flap.